NCT02070744

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-661	Tablet, oral use
DRUG	Ivacaftor	Film coated tablet, oral use
DRUG	Placebo matched to VX-661	Tablet, oral use
DRUG	Placebo matched to Ivacaftor	Film coated tablet, oral use

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-05-27
• Completion: 2016-05-27
• First posted: 2014-02-25
• Last updated: 2025-09-24
• Results posted: 2018-04-13

Locations

23 sites across 1 country: United States